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Open-Label Extension of EDG-5506 in Participants With Becker Muscular Dystrophy

NCT06066580 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2026-05-06

No results posted yet for this study

Summary

EDG-5506-203 MESA is an open-label extension study to assess the long-term effect of sevasemten (EDG-5506) on safety, biomarkers, and functional measures in adults and adolescents with Becker muscular dystrophy

Conditions

  • Becker Muscular Dystrophy

Interventions

DRUG

Sevasemten

Sevasemten is administered orally once per day

Sponsors & Collaborators

  • Medpace, Inc.

    collaborator INDUSTRY

  • Edgewise Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Joanne M. Donovan, MD, PhD · Edgewise Therapeutics, Inc.

  • Roxana D. Dreghici, MD · Edgewise Therapeutics, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-02
Primary Completion
2031-02-28
Completion
2031-02-28
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Denmark
  • France
  • Germany
  • Israel
  • Italy
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06066580 on ClinicalTrials.gov